Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.

Helio's Health

Status: Completed

Conditions: Neuropathic Pain; Chronic Pain; Acute Pain

Treatments: Drug: Placebo; Drug: Ketamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03105765

HSK007

Details and patient eligibility

About

Chronic Pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. The continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain. The investigators record the incidence and severity of acute pain and neuropathic pain during a seven day period after thoracotomy as well as the incidence of chronic pain and neuropathic pain after one and three month period. Parallel Group design, comparing one Group with a continuous application (24 hours) of ketamine against a Placebo Group.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• posterolateral thoracotomy for lung parenchyma resection
• informed consent
• ASA (American Society of Anesthesiologists) Status I-III

Exclusion criteria

• history of chronic pain
• history of neuropathic pain
• pregnancy or breastfeeding
• participation in another trial
• hypersensitivity for ketamine
• medication with can influence neuropathic pain (gabapentin, clonazepam)
• history of neurological or behavioral illness
• history of alcohol abuse
• history of chemotherapy or radiation
• opioid medication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Ketamine

Active Comparator group

Description:

The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium. Ketamine 0,2 mg/kg ideal Body weight per hour for 24 hours.

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium. Placebo (normal Saline) for 24 hours.

Treatment:

Drug: Placebo